Plante S, Strauss B H, Goulet G, Watson R K, Chisholm R J
Division of Cardiology, Centre Hospitalier Universitaire de Sherbrooke, Canada.
J Am Coll Cardiol. 1994 Nov 15;24(6):1475-81. doi: 10.1016/0735-1097(94)90142-2.
This study was designed to determine the effectiveness, safety and costs associated with reuse of angioplasty catheters and to compare these results with those of a contemporary center that employed a single-use strategy.
Coronary angioplasty is an important but expensive procedure. To overcome the financial constraints of the Canadian health care system, reuse of angioplasty catheters is routinely practiced in some institutions.
In a prospective observational study, data forms were completed after each angioplasty procedure and before patient discharge over a 10-month period.
A total of 693 patients underwent coronary angioplasty in the two centers. Clinical and lesion characteristics were similar except for a higher incidence of unstable angina at the reuse center (p < 0.005). The angiographic success rate was identical (88%) at both centers. The reuse center utilized more balloon catheters/lesion (mean +/- SD 2.4 +/- 1.5 vs. 1.2 +/- 0.5, p < 0.00001) and had a higher incidence of initial balloon failure (10.2% vs. 3.3%, p < 0.0001). Significant prolongation of the procedure time (81 +/- 41 vs. 68 +/- 32 min, p < 0.0001) and increased volume of contrast medium (201 +/- 86 vs. 165 +/- 61 ml, p < 0.0001) were seen in the reuse center. A higher rate of adverse clinical events (7.8% vs. 3.8%, p < 0.025) was observed in the reuse center, especially in patients with unstable angina.
The reuse strategy was associated with a higher rate of adverse events, prolonged procedure time and increased use of contrast medium, especially in lesions that were not crossed by the initial balloon and in patients with unstable angina. Whether these differences are related to the reuse strategy or to differences in patient groups cannot be ascertained by this observational study. A multicenter randomized trial is required to further assess the safety and the cost/benefit ratio of this strategy.
本研究旨在确定血管成形术导管再利用的有效性、安全性和成本,并将这些结果与采用一次性使用策略的当代中心的结果进行比较。
冠状动脉血管成形术是一项重要但昂贵的手术。为克服加拿大医疗保健系统的财政限制,一些机构常规进行血管成形术导管的再利用。
在一项前瞻性观察性研究中,在10个月期间,每次血管成形术后及患者出院前完成数据表格。
两个中心共有693例患者接受了冠状动脉血管成形术。除再利用中心不稳定型心绞痛发生率较高外(p<0.005),临床和病变特征相似。两个中心的血管造影成功率相同(88%)。再利用中心每个病变使用的球囊导管更多(平均±标准差2.4±1.5对1.2±0.5,p<0.00001),初始球囊失败发生率更高(10.2%对3.3%,p<0.0001)。再利用中心手术时间显著延长(81±41对68±32分钟,p<0.0001),造影剂用量增加(201±86对165±61毫升,p<0.0001)。再利用中心不良临床事件发生率较高(7.8%对3.8%,p<0.025),尤其是不稳定型心绞痛患者。
再利用策略与较高的不良事件发生率、延长的手术时间和增加的造影剂使用有关,尤其是在初始球囊未通过的病变和不稳定型心绞痛患者中。这些差异是与再利用策略有关还是与患者群体差异有关,本观察性研究无法确定。需要进行多中心随机试验以进一步评估该策略的安全性和成本效益比。